Acta Pharm. 57
(2007) 479-489
Original research paper
Design and evaluation of sustained release
bi-layer tablets of propranolol hydrochloride
CHINAM
NIRANJAN PATRA, ARETHI BHARANI KUMAR, HEMANT KUMAR PANDIT, SATYA PRAKASH SINGH
and MEDURI VIMALA DEVI
P.G. Department of
Pharmaceutics, College of Pharmaceutical Sciences, Berhampur-760002, Orissa, India
Accepted August 20, 2007
The objective of the present research was to develop a bilayer tablet of propranolol
hydrochloride using superdisintegrant sodium starch glycolate for the fast release layer and water immiscible
polymers such as ethyl cellulose, Eudragit RLPO and Eudragit RSPO for the sustaining layer. In vitro dissolution studies were
carried out in a USP 24 apparatus I. The formulations gave an initial burst
effect to provide the loading dose of the drug followed by sustained release
for 12 hrs from the sustaining layer of matrix embedded tablets. In vitro dissolution kinetics followed the
Higuchi model via a non-Fickian diffusion controlled
release mechanism after the initial burst release. FT-IR studies revealed that
there was no interaction between the drug and polymers used in the study.
Statistical analysis (ANOVA) showed no significant difference in the cumulative
amount of drug release after 15 min, but significant difference (p < 0.005) in the amount of drug released after 12 h from optimized
formulations was observed.
Keywords: propranolol hydrochloride, bilayer tablets, sodium
starch glycolate, water immiscible polymers,
statistical analysis